BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 1912065 · Received December 1, 2010

    Report

    Report Number
    1061932-2010-00236
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010064
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED WITH THE REPLACEMENT CONTROL MATERIAL. THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE NEW LOT OF CONTROL PRODUCT LEAKED AFTER THE CAP BECAME LOOSE DURING SHIPMENT. THE COULTER AC*T DIFF ANALYZER IS ASSOCIATED WITH THIS ACCOUNT. THE LEAKING CONTROL MATERIAL WAS CONTAINED WITHIN THE INSIDE OF THE CONTROL PACKAGING. THE CUSTOMER DISPOSED OF THE LEAKING VIAL IN THE BIOHAZARD WASTE. THERE WAS NO EXPOSURE OF THE CONTROL MATERIAL TO OPEN WOUNDS OR MUCOUS MEMBRANES (EYES, MOUTH, AND NOSE). NO ONE SOUGHT OUT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T DIFF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1